Expert questions survival benefit of cancer drugs

An expert has questioned whether it is ethical to spend vast sums on cancer drugs conferring limited survival benefit

Writing in the British Medical Journal, Peter Wise, a former consultant at Charing Cross Hospital in London, said spending an annual six figure sum to prolong life by a few weeks or months “may be inappropriate” for many patients. In 2015, global sales of cancer drugs were around $110bn, he noted.

He says improvements in diagnosis and treatment may have contributed more to an increase in survival over the last four decades.

He cited study evidence showing 48 new drug regimens approved by the US Food and Drug Administration between 2002 and 2014 conferred a median overall survival benefit of 2.1 months.

Wise argued that new drugs could only partly explain why relative survival in adults with solid cancer has increased from 49% to 68% over 40 years in the US.

Developments in early diagnosis and treatment may have “contributed much more”, calling for stricter drug approval criteria and improved consent processes “to achieve ethical treatment and reduce cancer costs.”

He added: “The approval of drugs with such small survival benefits raises ethical questions, including whether recipients are aware of the drugs’ limited benefits, whether the high cost:benefit ratios are justified, and whether trials are providing the right information.”

Surrogate endpoints, used by regulators to quickly approve badly-needed new drugs, are not always true indicators of survival benefit, said Wise. And he warned that the marginal responses in clinical trials may not even apply to the majority of patients treated outside trials.

The recent integration of the Cancer Drugs Fund into the National Institute of Health and Care Excellence (NICE) in England might make it possible to monitor the “real world benefit” of these drugs, Wise added.

He also raises concern over the FDA’s accelerated and “breakthrough” category which, he says, compounds the risk of premature approval on limited evidence.

A lack of fully informed consent for cancer treatment is also a concern, often leading to misinformed patients with unrealistic expectations, he adds.

“Good cancer care demands empowerment of patients with accurate, impartial information followed by genuinely informed consent in both the clinical trial and therapeutic settings,” he concluded.